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Quality & Compliance

Quality Assurance

Quality Assurance
All of Sartorius Biohit’s products and processes from R&D to production and from marketing to sales comply with ISO 13485 quality standards, which cover the manufacture of medical device, and also with ISO 9001 and ISO 14001 quality and environmental standards. ISO 8 Clean Room certification is being sought for the pipette tip production process in Kajaani.

Biohit manufactures almost all of its products itself, using clean rooms and demanding raw materials. Pipette components and tips are designed and made by Sartorius Biohit in Finland under strict quality controls. Our pipette assembly plant in Shuzou, China, complies with the same quality standards.
  • The Quality Management System of Sartorius Biohit complies with the ISO 9001 and the ISO 13485
  • The Sartorius Biohit Environmental Quality Management complies with the ISO 14001 Environmental standard.
  • Certified by Det Norske Veritas (DNV)
  • Accredited pipette calibration laboratories in Finland (FINAS), Germany (DKD), France (COFRAC), Russia (Gosstandart) and the UK (UKAS) are accredited and ISO 17025 certified.

Quality Policy

Quality Policy
Sartorius Biohit products are manufactured according to the ISO 9001, ISO 13485 and ISO 14001 quality and environmental standards in the plants in Kajaani and Helsinki, Finland, and Suzhou, China.

In the liquid handling product manufacturing units in Helsinki and Kajaani, investments have been made specially in the automation of injection moulding, materials handling, production, and warehousing. The injection moulding department produces precision moulded plastic components, pipettor parts and disposable pipette tips. These lines enable a manyfold increase in fully-automated tip production in clean-room cells. 

Components are made in Helsinki, the Kajaani plant is specialised in pipette assembly and automated pipette tip production and the pipette assembly plant in China primarily serves the Asian market.
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